TRIDENT SCREW HOLE PLUG AND TRIDENT BONE SPIKE— 510(k) K022799

Substantially Equivalent

Howmedica Osteonics Corp.

FDA 510(k) clearance K022799 for TRIDENT SCREW HOLE PLUG AND TRIDENT BONE SPIKE, Substantially Equivalent on 2002-11-21. Applicant: Howmedica Osteonics Corp..

Clearance details

Applicant: Howmedica Osteonics Corp.
Product code: Code JDI
Advisory panel: Orthopedic
Date received: 2002-08-23
Decision date: 2002-11-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Allendale, NJ, US

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Adverse events under product code JDI

product code JDI

Death: 65
Injury: 12,943
Malfunction: 1,681
Total: 14,689

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.